: We have been motivated to propose an open-label, dose-escalation, clinical pilot trial of Pamidronate infusions for the relief of chronic low-back pain by: (1) human studies that have demonstrated the analgesic effect of Pamidronate for cancer and non-cancer bone pain; (2) animal studies that have demonstrated the analgesic effect of this drug for pain unrelated to bone pathology; and (3) the impressive relief of non-malignant, chronic low-back pain among our patients treated with Pamidronate. Chronic low-back pain affects large segments of populations throughout the world, and is responsible for large costs in the form of suffering, lost workdays, and medical treatment. While Pamidronate infusions relieve bone pain related to Metastatic cancer, Paget's Disease, Ankylosing Spondylitis, and inflammatory bone and articular conditions, there have been no clinical trials of Pamidronate for chronic, mechanical low-back pain. The study participants will be 40 patients who have not had back surgery, and who have chronic, mechanical low-back pain associated with disc degeneration. Consistent with the success we have observed in patients with and without Osteoporosis, study participants will include individuals with and without Osteoporosis. They will be equally divided among five treatment groups (N=8 per group), who will receive between one and five 90 mg. Pamidronate infusions, respectively. There will be a one-month interval between infusions, and a 24-week follow-up period after the last infusion. Nightly, participants will electronically complete the Brief Pain Inventory (BPI). In addition, the research coordinator will administer the BPI, weekly, via telephone. The primary objective of the pilot is to determine the optimal dose of Pamidronate for a Phase III trial by comparing the different doses with respect to their tolerability and safety profiles, including their effect on bone remodeling. Very little is known about the effects of Pamidronate in individuals with normal bone turnover. Secondary aims include the determination of the duration of follow-up for the Phase 111 trial, and the assessment of the relationships of (1) pain intensity changes to baseline bone scan results, (2) changes in performance on the Simmonds Physical Performance Battery for Patients with Low-Back Pain, to the number of Pamidronate infusions and to changes in pain intensity scores, and (3) patient satisfaction to treatment regimen..
| Pappagallo, Marco; Breuer, Brenda; Lin, Hung-Mo et al. (2014) A pilot trial of intravenous pamidronate for chronic low back pain. Pain 155:108-17 |
